RHAPSODY MRI

K082126 · Grantadler Corporation · LJT · Nov 13, 2008 · General Hospital

Device Facts

• Record ID: K082126
• Device Name: RHAPSODY MRI
• Applicant: Grantadler Corporation
• Product Code: LJT · General Hospital
• Decision Date: Nov 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. The Rhapsody Port and Catheter are safe to use in an MRI environment.

Device Story

Subcutaneous, implanted, intravascular infusion port and catheter system. Device provides reliable repeated vascular access for delivery of medications, fluids, blood products, or blood sampling. Port manufactured from titanium with high-compression self-sealing silicone septum; catheter made of flexible, reinforced silicone. Suture sites on port base facilitate anchorage to underlying fascia. Intended for single-patient use. Device is MRI compatible. Operated by clinicians in clinical settings. Provides patient benefit by enabling repeated vascular access while maintaining MRI compatibility.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by performance testing and design verification testing for MRI compatibility.

Technological Characteristics

Materials: Titanium (port), silicone (septum and catheter). Form factor: Implantable subcutaneous port with catheter. Connectivity: None. Energy source: None (passive). Sterilization: Sterile.

Indications for Use

Indicated for patients requiring reliable repeated vascular access for delivery of medications, nutritional supplementation, fluids, blood, blood products, or blood sampling.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• GrantAdler - Rhapsody (K043178)

Submission Summary (Full Text)

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KU82136

# NOV 1 3 2008

# 510(K) SUMMARY (as required by 807.92(c))

| Regulatory Correspondent: | AJW Technology Consultants Inc.<br>962 Allegro Lane<br>Apollo Beach, FL 33572<br>Phone: [phone] |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | GrantAdler Corporation<br>1733 Park Street Suite 104<br>Naperville, IL 60563<br>Phone: [phone] |
| Contact Person: | Michael Loiterman |
| Date of Summary: | July 3, 2008 |
| Trade/Proprietary Name: | Rhapsody MRI |
| Classification Name: | Port & catheter, implanted, subcutaneous, intravascular |
| Product Code: | LJT |

### Device Description:

grantAdler Ports and Catheters are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, non-compressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia. The grantAdler port line is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood.

### Predicate Device:

K043178 - GrantAdler - Rhapsody

### Substantial Equivalence:

The Rhapsody MRI mects all established acceptance criteria for performance testing and design verification testing. The components of the Rhapsody MRI are substantially equivalent to the predicate devices as presented in this 510(k). The product is identical to the GrantAdler Rhapsody Access Port with different labeling and testing having been performed to demonstrate its substantial equivalence as a MRI Compatible Device.

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### Intended Use:

The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. The Rhapsody Port and Catheter are safe to use in an MRI environment.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three lines extending from the bottom of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 3 2008

GrantAdler Corporation C/O Arthur J. Ward, Ph.D. AJW Technology Consultants Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K082126

Trade/Device Name: Rhapsody MRI Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutancous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 3, 2008 Received: August 19, 2008

Dear Dr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Dr. Ward

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, pcrmits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suytie y. Michaud md.

Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

Devicc Name: Rhapsody MRI

Indications for Use:

The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINF-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L.K. mD

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: k082126